Engine pilot job description

The mission of Irvine Pilot Operations is to enable Edwards to achieve rapid product development cycles coupled with exceptional product reliability, efficient cost, and real-time product transfers through a strong partnership with the NPD teams and the global plant network. The Primary Objective for Advanced Catheter Pilot is to provide the MFG capabilities of Steerable Catheters in a highly capable and agile platform that provides service to our partners in early innovation, clinical EHU, and transfer to selected commercial sites.

The Senior Manufacturing Engineer will support engineering and validation activities related to establishing equipment capabilities, equipment procurement, IQ/SWV, process development, initial stabilization of new and in-sourced steerable catheter shafts for early human use as well as support of transfer activities. Additional objectives may include setting and optimizing cleanroom configurations to improve quality and performance, tooling and fixture design, DFM, new equipment design and/or integration, and process capability with cost analysis of priority projects. This role will directly interact with the Advanced Catheter COE and other cross-functional engineering resources to support development and transfer of new processes and technologies to manufacturing.
**Key Responsibilities:**

+ Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.

+ Draft, approve, execute, and maintain relevant documentation such as SOPs, specifications, drawings, process sheets, FMEAs, and facilitate validation protocols as necessary to support implementation of equipment projects, as well as new process integrations.

+ Develop training and JDOC documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.

+ Lead and establish project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).

+ Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods), employing technical design skills to re-design/design and ensure equipment, tools and fixtures are up to standards.

+ Guide manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.

+ Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations) as applicable.

+ Perform other duties and responsibilities as assigned.

**Basic Qualifications:**

+ Bachelor's Degree in Engineering or Scientific field.

+ Minimum of 4 years' experience in manufacturing engineering.

**Preferred Qualifications:**

+ Medical device manufacturing experience in steerable catheters, nitinol stents and/or braiding, catheters, delivery systems and/or interventional access devices is preferred.

+ Advanced degree or Six Sigma certification is preferred.

+ Familiarity with Design for Manufacturability and LEAN is preferred.

+ Proven expertise in usage of MS Office Suite including MS Project; MES and/or CAD experience preferred.

+ Strong verbal/written communication and interpersonal skills.

+ Strong project management skills.

+ Basic understanding of statistical techniques.

+ Previous experience in a manufacturing support role preferred.

+ Strong problem-solving, organizational, analytical and critical thinking skills.

+ Process Validation experience.

+ Capable of analyzing and solving complex problems through innovative thought and experience.

+ Ability to manage competing priorities in a fast-paced environment.

+ Ability to work well independently as well as part of a team.

+ Good leadership skills and ability to influence change.

+ Ability to interact professionally with all organizational levels.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.